ICH Guideline Q9 Quality Risk Management
1. INTRODUCTION
2. SCOPE
3. PRINCIPLES OF QUALITY RISK MANAGEMENT
4. GENERAL QUALITY RISK MANAGEMENT PROCESS
4.1 Responsibilities
4.2 Initiating a Quality Risk Management Process
4.3 Risk Assessment
4.4 Risk Control
4.5 Risk Communication
4.6 Risk Review
5. RISK MANAGEMENT METHODOLOGY
6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS
7.DEFINITIONS
8. REFERENCES
Annex I: Risk Management Methods and Tools
I.1 Basic Risk Management Facilitation Methods
I.2 Failure Mode Effects Analysis (FMEA)
I.3 Failure Mode, Effects and Criticality Analysis (FMECA)
I.4 Fault Tree Analysis (FTA)
I.5 Hazard Analysis and Critical Control Points (HACCP)
I.6 Hazard Operability Analysis (HAZOP)
I.7 Preliminary Hazard Analysis (PHA)
1.8 Risk Ranking and Filtering
I.9 Supporting Statistical Tools
Annex II: Potential Applications for Quality Risk Management
II.1 Quality Risk Management as Part of Integrated Quality Management
II.2 Quality Risk Management as Part of Regulatory Operations
II.3 Quality Risk Management as Part of development
II.4 Quality Risk Management for Facilities, Equipment and Utilities
II.5 Quality Risk Management as Part of Materials Management
II.6 Quality Risk Management as Part of Production
II.7 Quality Risk Management as Part of Laboratory Control and Stability Studies
II.8 Quality Risk Management as Part of Packaging and Labelling

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